Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM
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 280MM due to a defect discovered during a rework process. The set screw and sleeve assembly, which are supposed to fit together with interference, were found to have shifted from their proper installed location. This defect could prevent the product from assembling correctly with the mating screw and targeting jig. The affected devices were distributed nationwide in the United States as well as in Portugal and the Netherlands.
The recall involves three specific lot numbers with expiration dates ranging from May 2027 to June 2027. Affected consumers can identify the recalled product by Item No. 814611280 and the corresponding lot numbers and UDI codes listed above. The source document does not specify a remedy for consumers who have received or used 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. 814611280; Lot No. (Exp. Date) UDI: 459270 (05/18/2027) UDI (01)00887868039775 (17)270518 (10)459270; 858780 (06/16/2027) UDI (01)00887868039775 (17)270616 (10)858780; 972840 (06/15/2027) UDI (01)00887868039775 (17)270615 (10)972840
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.