Hgp ii acetabular cup bone screw selftap… recallZ-1683-2016 · Zimmer Manufacturing B.V. · initiated May 4, 2016
Class II Terminated All recalls posted in May 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer Manufacturing B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
FDA root cause category: Packaging change control
What the company is doing
All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Recall details
- Recall number
- Z-1683-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 4, 2016
- Posted by the FDA
- May 16, 2016
- Recalling firm
- Zimmer Manufacturing B.V.
- Quantity
- 1199
- Product code
- JDI
- FDA submissions
- K840643
- Distribution
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
Product description
Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560
Code information (models, lots, serial numbers)
LOTS: 63276979 63276976 63245682 63276975 63276977 63301523 63276980 63303436
Other devices under the same FDA submission
17 devices cleared under K840643 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- VerSys® 8018-32-02Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented21 reports
- VerSys® 8018-32-01Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED10 reports
- VerSys® 8018-28-02Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented9 reports
- NA 6624-65-30Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED7 reports
- NA 6624-65-40Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- NA 6624-65-50Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- VerSys® 8018-28-01Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- VerSys® 8018-32-03Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- VerSys® 8018-28-05Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- NA 6624-65-20Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- VerSys® 8018-28-03Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- NA 6624-65-25Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 73981).
- Z-1673-2016 · TerminatedZimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw Self…
- Z-1674-2016 · TerminatedZimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401
- Z-1676-2016 · TerminatedPeriarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116
- Z-1677-2016 · TerminatedZimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellou…
- Z-1684-2016 · TerminatedTrilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550 Bone screw 6.5x15 selftap 00625006515 Bone screw 6.5x20 selftap 0062500…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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