PCA
Skirtless 2 Degree 52' Taper Head
13manufacturers in China registered for this device type
3catalogue numbers in this listing
17510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K061168 |
| Record published | 2017-06-19 |
| Record revised | 2020-04-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6280-0-136 | Diameter: 36.0 Millimeter | In distribution |
| 6280-0-436 | Offset: 15.0 Millimeter | In distribution |
| 6280-0-036 | Offset: -3.0 Millimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Zimmer, Inc. | 836 |
| R3 | Smith & Nephew, Inc. | 497 |
| UniSyn Hip System | Shalby Advanced Technologies, Inc. | 247 |
| UniSyn® Hip System | Consensus Orthopedics, Inc. | 247 |
| Reflection | Smith & Nephew, Inc. | 170 |
| Instrument | Howmedica Osteonics Corp | 167 |
| Echelon | Smith & Nephew, Inc. | 159 |
| B-P Total HIP System | Endotec, Inc. | 151 |
| ZCA® | Zimmer, Inc. | 149 |
| Omnifit | Howmedica Osteonics Corp | 149 |
| Ringloc HIP System | Biomet Orthopedics | 139 |
| Profemur | Microport Orthopedics Inc. | 113 |
Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193429 | 2020-08-13 |
| K120578 | 2012-03-29 |
| K110290 | 2011-09-27 |
| K052748 | 2005-12-02 |
| K051363 | 2005-06-23 |
| K050138 | 2005-03-21 |
| K031730 | 2003-08-29 |
| K031744 | 2003-08-08 |
| K022799 | 2002-11-21 |
| K022077 | 2002-07-25 |
| K021310 | 2002-05-21 |
| K020989 | 2002-04-26 |
| K012026 | 2001-07-18 |
| K011623 | 2001-06-15 |
| K010757 | 2001-04-11 |
| K010310 | 2001-03-20 |
| K001956 | 2000-12-11 |
Recalls
18 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-08-28 | Class II | Under Investigation by firm | a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted. | 55 units (all OUS) | |
| 2024-08-05 | Class II | Process control | A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal. | 1 unit (OUS only) | |
| 2019-11-07 | Class II | Employee error | May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire | 20 units | 2020-08-31 |
| 2018-05-22 | Class II | Process control | The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011. | 2020-05-08 | |
| 2018-05-22 | Class II | Process control | The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011. | 2020-05-08 | |
| 2018-05-22 | Class II | Process control | The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011. | 2020-05-08 | |
| 2018-05-22 | Class II | Process control | The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011. | 2020-05-08 | |
| 2018-05-22 | Class II | Process control | The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011. | 2020-05-08 | |
| 2018-05-22 | Class II | Process control | The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011. | 2020-05-08 | |
| 2018-05-22 | Class II | Process control | The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011. | 2020-05-08 | |
| 2018-05-22 | Class II | Process control | The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011. | 2020-05-08 | |
| 2016-08-29 | Class II | Under Investigation by firm | Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads. | 42,519 units (total Catalog numbers) | 2017-05-02 |
| 2016-07-01 | Class II | Device Design | Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle. | 241 units | 2017-06-08 |
| 2015-10-15 | Class II | Under Investigation by firm | Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the US, although the 22 mm size was inadvertently omitted from 510(k) #K963612. | 1 unit | 2017-06-08 |
| 2015-02-03 | Class II | Under Investigation by firm | Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn’t be assembled with its corresponding V40 stem trunnion. | 9 units | 2017-04-07 |
| 2013-10-25 | Class II | Packaging process control | Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5. | 20 units | 2015-03-31 |
| 2012-07-16 | Class II | Device Design | Stryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem. | 301 units | 2015-09-09 |
| 2011-12-29 | Class II | Employee error | Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product. | 16,913 units | 2015-03-19 |
| 2010-03-31 | Not classified | Process control | One lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. The size 14 Large centralizers have been labeled as size 13 Medium centralizers and size 13 Medium centralizers have bee | 17 | 2010-07-09 |
| 2010-03-31 | Not classified | Process control | One lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. The size 14 Large centralizers have been labeled as size 13 Medium centralizers and size 13 Medium centralizers have bee | 15 | 2010-07-09 |
| 2010-03-29 | Not classified | Error in labeling | Stryker became aware that device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label. | 24 units | 2012-09-10 |
| 2008-11-13 | Not classified | Packaging | Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices. | 322 total units – all types | 2010-01-20 |
| 2008-11-13 | Not classified | Packaging | Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices. | 322 total units – all types | 2010-01-20 |
| 2008-11-13 | Not classified | Packaging | Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices. | 322 total units – all types | 2010-01-20 |
| 2008-11-13 | Not classified | Packaging | Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices. | 322 total units – all types | 2010-01-20 |
| 2007-12-18 | Not classified | Labeling design | The GMRS Proximal Femoral Surgical Protocol states ” The GMRS Proximal Femoral components are fully compatabile with all Stryker V40 femoral heads.” This statement is incorrect and conflicts with the Alumina Head label and packaging insert | 5869 | 2008-10-15 |
| 2007-11-15 | Not classified | Process design | Curvature Discrepancy –The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| 2007-11-15 | Not classified | Process design | Curvature Discrepancy –The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| 2007-11-02 | Not classified | Other | Fracture of Stem Neck – The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with certain Accolade TMZF femoral stems in p | 5,599 total units | 2010-08-30 |
| 2007-11-02 | Not classified | Other | Fracture of Stem Neck – The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with certain Accolade TMZF femoral stems in p | 5,599 total units | 2010-08-30 |
| 2007-11-02 | Not classified | Other | Fracture of Stem Neck – The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with certain Accolade TMZF femoral stems in p | 5,599 total units | 2010-08-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.