4.5 mm Malleolar Screw recallZ-2250-2014 · Zimmer, Inc. · initiated Jul 22, 2014
Class II Terminated All recalls posted in August 2014
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, Inc. 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
Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
FDA root cause category: Package design/selection
What the company is doing
On 7/22/14, Zimmer sent recall notification to the consignees explaining the issue, identifying affected product, providing the health risks, and instructing the consignees what to do for the recall. Questions or concerns, please contact Zimmer at 1-877-946-2761.
Recall details
- Recall number
- Z-2250-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 22, 2014
- Posted by the FDA
- Aug 16, 2014
- Recalling firm
- Zimmer, Inc.
- Quantity
- 47,682 units total
- Product code
- HWC
- FDA submissions
- K112885
- Distribution
- National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE
Product description
4.5 mm Malleolar Screw Sterile zimmer
Code information (models, lots, serial numbers)
Item Number 47-4845-025, 030, 035, 040, 050, 055, 060, 065, 070, -08
Other devices under the same FDA submission
3 devices cleared under K112885 — 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 47-4840-014-00Zimmer, Inc. · WASHER, BOLT NUT1 report
- NA 47-4840-035-01Zimmer, Inc. · WASHER, BOLT NUT1 report
- NA 47-4840-040-01Zimmer, Inc. · WASHER, BOLT NUT1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 68819).
- Z-2244-2014 · TerminatedMagna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer
- Z-2245-2014 · TerminatedMagna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer
- Z-2246-2014 · Terminated6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
- Z-2247-2014 · Terminated6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
- Z-2248-2014 · Terminated6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer
- Z-2249-2014 · Terminated6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
- Z-2251-2014 · Terminated4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer
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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