Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM
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, LH 130 DEG 11MM X 260MM distributed nationwide in the United States, as well as in Portugal and the Netherlands. During a rework process for a previous field action dated April 17, 2017, the set screw and sleeve assembly—which are designed to fit together with interference—were found to have become dislodged from their installed location. This dislodgement could prevent the product from assembling properly with the mating screw and targeting jig. The affected product is identified by Item No. 814611260, with multiple lot numbers and expiration dates ranging from May 21, 2027 to June 5, 2027.
The recall source does not specify a remedy or corrective action for consumers who may have this product.
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. 814611260; Lot No. (Exp. Date) UDI: 507350 (05/21/2027 UDI (01)00887868039768 (17)270521 (10)507350; 701700 (06/05/2027) UDI (01)00887868039768 (17)270605 (10)701700; 701720 (06/05/2027) UDI (01)00887868039768 (17)270605 (10)701720; 701780 (06/05/2027) UDI (01)00887868039768 (17)270605 (10)701780
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.