Screw, Fixation, Bone, Non-Spinal, Metallic

FDA product code NDJ · Class 2 · Orthopedic

Registered devices

1,380

Adverse events

Recalls

510(k) clearances

Recent recalls

Date	Firm	Reason
2015-04-29	Zimmer, Inc.	The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with the M/DN system. This has the potential to lead to a
2013-10-11	Zimmer, Inc.	Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this r
2010-11-08	Biomet Microfixation, Inc.	On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120)
2010-11-08	Biomet Microfixation, Inc.	On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120)
2006-06-26	Zimmer Inc.	Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
2006-06-26	Zimmer Inc.	Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
2006-06-26	Zimmer Inc.	Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
2006-06-26	Zimmer Inc.	Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
2006-06-26	Zimmer Inc.	Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
2006-06-26	Zimmer Inc.	Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.