Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. is recalling 638 units of its Affixus Hip Fracture Nail (130 DEG 11MM X 180MM, Item No. 814511180, Lot No. 459170, expiration date 05/18/2027) distributed nationwide in the US as well as in Portugal and the Netherlands. During a rework process for an earlier field action dated April 17, 2017, it was found that the set screw and sleeve assembly—which should maintain an interference fit—were no longer in their proper installed location on some units.
The misplaced components could prevent the product from assembling correctly with the mating screw and targeting jig, potentially affecting the functionality of the device. The source document does not specify a remedy or corrective action for 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. 814511180, Lot No. 459170, Exp. Date 05/18/2027, (01)00887868039102 (17)270518 (10)459170
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.