Periarticular plating system, cancellous bone screw… recallZ-1676-2016 · 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-1676-2016
- 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
- 99
- Product code
- HWC
- FDA submissions
- K111447
- 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
Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116
Code information (models, lots, serial numbers)
LOT: 63146423
Other devices under the same FDA submission
3 devices cleared under K111447 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 47-2348-012-35Zimmer, Inc. · Screw, fixation, bone2 reports
- NA 47-2348-016-35Zimmer, Inc. · Screw, fixation, bone1 report
- NA 47-2348-018-35Zimmer, Inc. · Screw, fixation, bone1 report
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-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-1683-2016 · TerminatedHgp 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 006624…
- 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.
How recalls are matched to devices · Editorial policy · Report an error on this page