The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1684-2016·Announced 2016-05-25

Zimmer Manufacturing Recalls Trilogy Self-Tapping Bone Screws Due to Tray Defect

Zimmer Manufacturing B.V. is recalling specific lots of Trilogy self-tapping bone screws because a small hole may be present in the inner tray, potentially compromising sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a packaging defect (hole in tray) without reporting any illnesses, injuries, or hospitalizations. Per the rubric, this aligns with a voluntary precautionary recall or low-risk contamination where harm has not yet been reported, fitting the Moderate (2) or High (3) range; however, given the lack of reported harm and the specific nature of the packaging defect, it is treated as a precautionary measure.

Plain-English summary

Zimmer Manufacturing B.V. is recalling specific lots of Trilogy self-tapping bone screws. The recall is due to a potential defect where a small hole may be present in the inner tray of the sterile packaging. This defect could compromise the sterile barrier of the medical device.

The affected products include various sizes of bone screws (4.5x25, 4.5x50, 6.5x15, 6.5x20, 6.5x25, and 6.5x30) with catalog numbers 00625004525, 00625004550, 00625006515, 00625006520, 00625006525, and 00625006530. The recall covers 3,893 units distributed worldwide, including the United States, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, the UK, Sweden, and Canada.

Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice: 63284570, 63284572, 63284573, 63187350, 63225662, 63272712, 63296123, 63301504, 63204283, 63209528, 63259476, and 63257719. If these lots are found, they should be quarantined and returned to the manufacturer or disposed of according to local regulations to prevent the use of potentially non-sterile implants.

The recalled product

Product
Trilogy 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 00625006520 Bone screw 6.5x25 selftap 00625006525 Bone screw 6.5x30 selftap 00625006530
Manufacturer
Zimmer Manufacturing B.V.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
3,893

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Zimmer Manufacturing B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

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