Affixus Hip Fracture Nail, RH 130 DEG 9MM X 400MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. recalled 638 units of the Affixus Hip Fracture Nail (RH 130 DEG 9MM X 400MM) 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 company detected that a set screw and sleeve assembly—which are designed to fit together tightly—had become dislodged from their proper location. This dislodgment could prevent the product from assembling correctly with the mating screw and targeting jig.
The affected device is Item No. 814509400 with three recalled lots: lot number 480050 (expiration 05/21/2027), lot number 701480 (expiration 06/03/2027), and lot number 701900 (expiration 06/03/2027), each with corresponding UDI codes. The source document does not specify what remedy an affected consumer should pursue.
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. 814509400; Lot No. (Exp. Date) UDI: 480050 (05/21/2027) UDI (01)00887868038921 (17)270521 (10)480050; 701480 (06/03/2027) UDI (01)00887868038921 (17)270603 (10)701480; 701900 (06/03/2027) UDI (01)00887868038921 (17)270603 (10)701900
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.