Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM, distributed nationwide in the US as well as in Portugal and the Netherlands. During a rework process related to an April 17, 2017 field action, the set screw and sleeve assembly were found to be missing from their installed location. This component is designed to have an interference fit and its absence could prevent proper assembly of the product with the mating screw and targeting jig.
The affected units are identified by Item No. 814509320 and include three lots with expiration dates in 2027. The specific lot numbers and UDI codes are UDI 555180 (05/24/2027), UDI 858640 (06/15/2027), and UDI 893090 (06/12/2027). The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Reason for recall: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig. Distribution: US nationwide distribution. Also Portugal and the Netherlands. Quantity: 638 units Lot/code info: Item No. 814509320; Lot No. (Exp. Date) UDI: 555180 (05/24/2027) UDI (01)00887868038884 (17)270524 (10)555180; 858640 (06/15/2027) UDI (01)00887868038884 (17)270615 (10)858640; 893090 (06/12/2027) UDI (01)00887868038884 (17)270612 (10)893090
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.