Affixus Hip Fracture Nail, RH 125 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 125 DEG 9MM X 320MM, distributed nationwide in the United States as well as in Portugal and the Netherlands. During rework procedures related to an earlier April 17, 2017, field action, the set screw and sleeve assembly—which are designed to fit together with an interference fit—were found to be missing from their installed location on some units. This displacement could prevent the product from assembling properly with the mating screw and targeting jig.
The affected units have item number 814309320 with two lot numbers: UDI 669850 (expiration 06/15/2027) and UDI 737670 (expiration 06/14/2027). The source document does not specify a remedy or instructions for what affected consumers should do.
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. 814309320; Lot No. (Exp. Date) UDI: 669850 (06/15/2027) UDI (01)00887868038006 (17)270615 (10)669850; 737670 (06/14/2027) UDI (01)00887868038006 (17)270614 (10)737670
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.