Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1683-2016·Announced 2016-05-25

Zimmer Manufacturing Recalls Hip and Trauma Implant Screws Due to Tray Defect

Zimmer Manufacturing B.V. is recalling specific lots of sterile Hip and Trauma Implant Screws because a small hole may be present in the inner tray.

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, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The defect is a packaging issue (hole in tray) that risks sterility, but no specific injuries or illnesses are reported in the source text, fitting the Moderate category for low-risk contamination or precautionary measures.

Plain-English summary

Zimmer Manufacturing B.V. is recalling specific lots of sterile Hip and Trauma Implant Screws. The recall involves the HGP II acetabular cup bone screw self-tap in various sizes, including 6.5x15mm, 6.5x20mm, 6.5x25mm, 6.5x35mm, 6.5x55mm, and 6.5x60mm. A total of 1,199 units are affected by this action.

The reason for the recall is that a small hole may be present in the inner tray of the sterile packaging for these specific lots. This defect could potentially compromise the sterile barrier of the device. The affected lots are 63276979, 63276976, 63245682, 63276975, 63276977, 63301523, 63276980, and 63303436.

The products were distributed worldwide, including in 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 these specific lot numbers and stop using the affected devices if found.

The recalled product

Product: 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…
Manufacturer: Zimmer Manufacturing B.V.
Category: Medical Device — Orthopedic Implants
Hazard: packaging-defect
sterility-compromise
Affected units: 1,199

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 →

Same manufacturer · Zimmer Manufacturing B.V.

See all →

High
Zimmer 3.5 mm Cortical Screws Recalled for Potential Sterility Compromise
FDA (Devices) · 2016-05-25
Moderate
Zimmer 2.7 mm Cortical Screws Recalled for Potential Tray Hole
FDA (Devices) · 2016-05-25
High
Zimmer VersaFx Femoral Fixation System Screws Recalled for Sterility Concerns
FDA (Devices) · 2016-05-25
High
Zimmer Herbert Cannulated Bone Screw Recall for Sterility Concerns
FDA (Devices) · 2016-05-25
Moderate
Zimmer Recalls Sterile Hip and Trauma Implant Screws Due to Tray Defect
FDA (Devices) · 2016-05-25

Same hazard · packaging defect